Akanda will supply Tetra Bio-Pharma with pharmaceutical-grade cannabis for the FDA trials of a new inhaled cannabinoid-based drug for cancer pain.
Akanda is making its first entry into drug cannabinoid development as it partners with Tetra Bio-Pharma to supply medical-grade cannabis for the global commercialisation of a new cannabis-based medicinal product for cancer pain. Tetra’s QIXLEEFTM is a botanical inhaled drug currently being studied in two US Food and Drug Administration (FDA) authorised clinical trials.
Under the multi-year agreement, Akanda will supply the Candian-based company with premium THC and CBD flower, and will provide regulatory, quality and pharmaceutical manufacturing services for the drug’s clinical development and marketing authorisation.
The companies estimate the total addressable market for QIXLEEF™ to be nearly $1.7 billion by 2028.
The supply of cannabis flower starts in the third quarter of 2022 and is anticipated to increase incrementally over the succeeding years based on growing demand and commercialisation of Tetra’s cannabinoid-derived medicines.
Akanda will also act as a contract development and manufacturing organisation (CDMO) for Tetra’s clinical drug and commercial supply programmes.
The international cannabis company said it will provide Tetra with a range of services, including regulatory affairs, quality control and stability testing through Akanda’s internal lab, along with manufacturing capabilities. Upon FDA approval, the anticipated supply commitments could reach over 10 metric tonnes per year.
“This supply agreement with Tetra is a major milestone in Akanda’s journey in becoming a cannabis platform company serving all regulated markets in the EMEA region,” commented Tej Virk, CEO of Akanda. “In supporting a terrific partner with a mission to improve patient health and quality of life through cannabinoid-derived medicine, we are demonstrating that cannabis can fit into the traditional public sector model, with the expectation of reimbursement.
“Simultaneously, we are productively utilising our diverse capabilities to support clinical trials for pharma-grade cannabinoids. If approved, we expect to provide flower for the authorised compound, potentially creating a significant, incremental revenue stream for Akanda. This opportunity could only have been possible with our state-of-the-art facilities that we gained through the acquisition of Holigen in May.”
Tetra, a leader in drug discovery and development for cannabinoid-based medicines, is focusing on therapeutic areas of inflammation, pain, ophthalmology and oncology using multiple delivery systems.
QIXLEEF™ is being used in the phase 2 clinical trial, REBORN, which has been authorised by the FDA to evaluate inhaled cannabinoids against a class of immediate-release oral opioids for the management of breakthrough cancer pain. It is also being used in the FDA-authorised phase 2 clinical trial, PLENITUDE, to evaluate the safety and efficacy of inhaled cannabinoids to relieve uncontrolled pain in patients with advanced cancer.
“Tetra has been looking for quite a while to find a global strategic CDMO partner, and we believe that Akanda is a perfect fit from a vision standpoint,” said Guy Chamberland, MSc, PhD, CEO and chief regulatory officer at Tetra. “This partnership will allow Tetra to secure a robust and trustable source for its clinical drug supply and for QIXLEEF™ commercialisation plans.
“Aside from quality, Akanda will rapidly automate our process and increase our capacity, resulting in a 67% reduction of our cost of goods sold (COGS). Establishing a defined source of high-quality ingredients is important for Tetra, and we are excited to advance a productive collaboration with Akanda as we advance target drugs through the regulatory process.”
The partnership will bring Akanda into the cancer pain medical market for the first time. The company’s president Dr Akkar-Schenkl said the collaboration with Tetra will put both firms on the path to becoming the “ambassadors for cancer pain treatment”.
“This collaboration transitions our Sintra facility into a global CDMO for cannabinoid-based pharmaceuticals as we build up our internal laboratory capacity and manufacturing under EU GMP,” said Dr Akkar-Schenkl. “The pharmaceutical-grade flower and the level of pharmaceutical excellence in manufacturing, quality operations and regulatory affairs we will be providing into these projects is our fundamental commitment to worldwide palliative care in pain treatment in the field of oncology.
“The bioburden quality of the flower we will be providing for this delicate patient population can only be managed under stringent manufacturing conditions, special regulatory and pharmaceutical know-how.”
